Health Canada — Medical Devices · Canada · 2020-05-22 · Type II
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Reported risk: Stryker has become aware via a single customer complaint [June 2018] that LIFEPAK 500 AEDs in high-use environments (Emergency Medical Services) may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. Wear-through of the connector exposes base metal on which an oxide layer may form and result in the device not recognizing a patient is connected. When this circumstance arises, the device will provide the user the "CONNECT ELECTRODES" message.
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